Clinical Trials Logo

Clinical Trial Summary

Myelomeningocele is a neural tube defect that occurs between the third and fourth week of gestation. Functional impairment occurs due to dysplasia of the nerve roots, which can lead to flaccid paralysis and sensory-motor dysfunction below the level of the lesion. Although advances in the multidisciplinary treatment of myelomeningocele have led to functional improvements in affected children, novel therapeutic modalities, such as photobiomodulation (PBM), could be a promising complement to treatment. Objective: Evaluate the effectiveness of PBM combined with physiotherapeutic exercises on the sensory-motor response in individuals with myelomeningocele at the lower lumbar and sacral level. Participants will be recruited from the Integrated Health Clinic of University Nove de Julho and randomized into two groups: Grupo 1 - treatment with PBM at a wavelength of 808 nm + physical therapy; Grupo 2 - sham PBM + physical therapy. Evaluations will involve electromyography of the gastrocnemius, tibialis anterior and rectus femoris muscles of both lower limbs. Balance will be evaluated using the Pediatric Balance Scale. The sensory evaluation will be performed using the Semmes-Weinstein monofilament kit (Smiles®). BDNF levels will be determined using ELISA. The data will be analyzed with the aid of GraphPad PRISM version 7.0. The Kolmogorov-Smirnov test will be used to determine the normality of the data. Variables that fit the Gaussian curve will be expressed as mean and standard deviation values. The t-test will be used for the comparisons between groups, with the level of significance set to 95% (p < 0.05).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04035863
Study type Interventional
Source University of Nove de Julho
Contact
Status Not yet recruiting
Phase N/A
Start date September 2, 2019
Completion date May 3, 2020

See also
  Status Clinical Trial Phase
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Completed NCT03162484 - Physical Activity and Chronic Acquired Brain Injury N/A
Completed NCT02915913 - Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults N/A
Terminated NCT02936726 - Examining Exercise, Health Coaching and Meditation for University Employees N/A
Completed NCT02329262 - A Skills-based RCT for Physical Activity Using Peer Mentors N/A
Completed NCT02158130 - Effects of Aerobic Exercise Detraining N/A
Terminated NCT01404039 - Investigating Motor Cortex Processing for Pain Modulation Phase 1
Completed NCT01188044 - Validating Accelerometers to Study Physical Activity of Toddlers N/A
Completed NCT01697124 - The Children in Action Feasibility Study N/A
Completed NCT03695523 - PLAY (PhysicaL ActivitY) Policy Study N/A
Active, not recruiting NCT05012241 - The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis
Recruiting NCT03826030 - Transcranial Direct Current Stimulation for Post-stroke Motor Recovery Phase 2
Completed NCT05033197 - Physical Activity, Cognition, Motor Skills, and Well-beings N/A
Completed NCT03146169 - Training Program for Community Health Campaign: Fitter Families Project N/A
Completed NCT03166020 - Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident N/A
Recruiting NCT02264275 - Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents N/A
Completed NCT02432924 - Using Combined Instantaneous and Multidimensional Feedback to Support a Change in Physical Activity Behaviour N/A
Completed NCT01697475 - Text-Messaging to Motivate Walking in Older African Americans N/A
Completed NCT04547569 - Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning N/A
Recruiting NCT05010993 - Establishing Czech Norms of Selected Standardized Tests